Stryker Neurovascular — Class II medical device recall Z-0065-2020
Terminated recall by Stryker Neurovascular, reported 2019-10-16. Labeling error; 8F Balloon Guide Catheters have been packaged within 9F Balloon Guide Catheter packaging
| Recall number | Z-0065-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Neurovascular, Fremont, CA, United States |
| Recall initiated | 2018-11-13 |
| Classified | 2019-10-08 |
| Reported by FDA | 2019-10-16 |
| Terminated | 2020-08-03 |
| Countries outside the US | AT, BE, CH, CZ, DE, FI, FR, IL, NL, PT, SE |
| Quantity | 190 catheter |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00815742000771 |
| Lot numbers | 0000010779 |
| Model numbers | 0459, 90077 |
Product
Stryker Neurovascular, Merci 9F, 80cm, Balloon Guide Catheter, REF 90077, CE 0459, UPN Product No. 90077, UDI #: (01)00815742000771
Reason for recall
Labeling error; 8F Balloon Guide Catheters have been packaged within 9F Balloon Guide Catheter packaging
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0065-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.